- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06727591
Evaluation of Horizontal Anterior Mandibular Augmentation With Split Bone Block Technique From the Chin
December 9, 2024 updated by: hossam samy mohamed saleh
The aim of this study was to compare clinically and radiographically bone gain, healing of the surgical site, healing of the grafted bone and stability of the grafted area following horizontal ridge augmentation at anterior mandible using split bone block from the chin area.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandria, Egypt, 21527
- Faculty of Dentistry, Alexandria University
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient with missing anterior mandibular teeth
- horizontal bone width < 5 mm
- Adequate zone of keratinized tissue
Exclusion Criteria:
- Presence of infection or periapical lesions in adjacent teeth
- Medically compromised patients with a condition that affect the procedure
- Insufficient inter-arch distance
- Bruxism or clenching
- Alcoholism
- Smokers
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Horizontal Ridge Augmentation with Split Bone Block
|
An intraoral crestal incision with/out vertical arms was performed on alveolar ridge using blade no.15.
After flap reflection, patroning the defect to help guide the area to be grafted from the donor site.
At the chin area (donor site) unicortical cuts will be made at least 5 mm inferior to root tips, 5 mm superior to inferior border of mandible and 5 mm away from the mental foramen.
The graft was luxated and split into two bone shells each 1 ~ 2 mm in thickness using disc.
The bone shells and the donor site were scrapped for autogenous graft particles.
Decortication of the recipient site.
The graft was stabilised into the recipient site using two or more self tapping titanium screws placed midway corono-apical in the bone shell following the ridge contour.
The autogenous particles were packed into the space between the split bone block and the ridge.
Collagen sponge was used to cover the donor site.
After 4 months the site was approached for implant placement using crestal incision
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain
Time Frame: up to 2 weeks
|
It was assessed through a 10-point Visual Analogue Scale (VAS).
The categories were as follows (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
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up to 2 weeks
|
|
Implant stability
Time Frame: up to 3 months
|
Implant stability was measured using Osstell. Osstell measures the resonance frequency which indicated the implant stability. It has a scale from 1 to 100 where:
|
up to 3 months
|
|
Amount of horizontal bone gain
Time Frame: up to 4 months
|
This was measured on cone beam computed tomography (CBCT) by comparing pre- and post-operative bone width at specific levels around the implant.
|
up to 4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 10, 2023
Primary Completion (Actual)
October 20, 2024
Study Completion (Actual)
October 20, 2024
Study Registration Dates
First Submitted
December 4, 2024
First Submitted That Met QC Criteria
December 9, 2024
First Posted (Estimated)
December 11, 2024
Study Record Updates
Last Update Posted (Estimated)
December 11, 2024
Last Update Submitted That Met QC Criteria
December 9, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- #8/2023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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